Pharmacy Prior Authorization Criteria

Oxbryta (voxelotor) - PA, NF

Indications for Prior Authorization

Oxbryta (voxelotor)

• For diagnosis of Sickle Cell Disease
  Indicated for the treatment of sickle cell disease (SCD) in adults and pediatric patients 4 years of age and older.

  This indication is approved under accelerated approval based on increase in hemoglobin (Hb). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Criteria

Oxbryta

Prior Authorization (Initial Authorization)

Length of Approval: 12 Month(s)

• Diagnosis of sickle cell disease
AND
• Patient is 4 years of age and older
AND
• Patient demonstrates hemoglobin level that does not exceed 10.5 g/dL prior to therapy initiation [2]
AND
• Trial and failure or inadequate response, contraindication, or intolerance to hydroxyurea [3, 4]
AND
• Prescribed by or in consultation with one of the following:
• Hematologist/Oncologist
• Specialist with expertise in the diagnosis and management of sickle cell disease

Oxbryta

Prior Authorization (Reauthorization)

Length of Approval: 12 Month(s)

• Patient demonstrates positive clinical response to therapy (e.g., an increase in hemoglobin level of greater than or equal to 1 g/dL from baseline, decreased annualized incidence rate of VOCs)
AND
• Patient demonstrates hemoglobin level that does not exceed 10.5 g/dL

Oxbryta

Non Formulary

Length of Approval: 12 Month(s)

• Diagnosis of sickle cell disease
AND
• Patient is 4 years of age and older
AND
• Patient demonstrates hemoglobin level that does not exceed 10.5 g/dL prior to therapy initiation [2]
AND
• Paid claims or submission of medical records (e.g., chart notes) confirming trial and failure or inadequate response, contraindication, or intolerance to hydroxyurea [3, 4]
AND
• Prescribed by or in consultation with one of the following:
• Hematologist/Oncologist
• Specialist with expertise in the diagnosis and management of sickle cell disease

P & T Revisions

2024-01-03, 2023-10-10, 2023-01-31, 2023-01-04, 2021-12-27, 2020-12-30, 2020-02-13, 2020-01-15

References

1. Oxbryta (voxelotor) [Prescribing Information]. South San Francisco, CA. Global Blood Therapeutics, Inc; August 2023.
2. Vichinsky E, Hoppe C, Ataga K et al. A Phase 3 Randomized Trial of Voxelotor in Sickle Cell Disease. New England Journal of Medicine. 2019;381(6):509-519. doi:10.1056/nejmoa1903212.
3. Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014. Nhlbi.nih.gov. https://www.nhlbi.nih.gov/sites/default/files/media/docs/sickle-cell-disease-report%20020816_0.pdf. Published 2014. Accessed December 1, 2021.
4. Brawley O, Cornelius L, Edwards L et al. National Institutes of Health Consensus Development Conference Statement: Hydroxyurea Treatment for Sickle Cell Disease. Ann Intern Med. 2008;148(12):932. doi:10.7326/0003-4819-148-12-200806170-00220.

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Revision History

• 2024-01-03: 2024 UM Annual Review. No criteria changes. Updated "Documentation of" to "Patient demonstrates." Background updates
• 2023-10-10: Program update to standard reauthorization language. No changes to clinical intent.
• 2023-01-31: Added new strength of Oxbryta 300mg tablets.
• 2023-01-04: 2023 UM Annual Review. No criteria updates. Updated references
• 2021-12-27: 2022 UM Annual Review. Added age criterion in initial authorization to align with prescribing information. Updated indication and references. Added Non-Formulary criteria.
• 2020-12-30: 2021 UM Annual Review.
• 2020-02-13: Removed "documentation of at least one VOC event in the past 12 months" from initial authorization per consultant feedback. Reworded age criterion to say at least 12 years of age or "older" instead of 12 years of age or "greater" per Feb P&T feedback.
• 2020-01-15: New Program. Pending Jan 2020 P&T Decision.

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